FDA.reportPublic FDA data

Glide

Primary DI
00850004850756
Brand
Glide
Company
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
Model
94001
Device description
Core2 Fabrication Kit
Published
2024-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
IQZHand, External Limb Component, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
IQZHand, External Limb Component, PoweredPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240884000Glide (91000-GL-X)Infinite Biomedical Technologies, LLC2024-04-15GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004850756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004850756008500048507568500048507560850004850756

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeAn electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037376022
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004850879Glide94001-42025-03-20
00850004850886Glide94001-82025-03-20
00850004850626Glide91000-GL-B2024-04-30
00850004850633Glide91000-GL-C2024-04-30
00850004850640Glide91000-GL-D2024-04-30
00850004850657Glide91000-GL-E2024-04-30
00850004850664Glide91000-GL-F2024-04-30
00850004850671Glide91000-GL-G2024-04-30
00850004850688Glide91000-GL-H2024-04-30
00850004850695Glide91000-GL-I2024-04-30
00850004850701Glide91000-GL-J2024-04-30
00850004850718Glide91000-GL-K2024-04-30
00850004850725Glide91000-GL-L2024-04-30
00850004850732Glide91000-GL-M2024-04-30
00850004850749Glide91000-GL-N2024-04-30
00850004850763Glide95001-ST2024-04-30
00850004850770Glide90010-GL2024-04-30
00850004850787Glide90041-BK2024-04-30
00850004850794Glide90041-RD2024-04-30
00850004850800Glide90041-BL2024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
05905515340793MyoSenseAETHER BIOMEDICAL SP Z O OIQZ2026-10-08
05905515340618ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340632ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340717ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340731ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340755ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340779ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340816ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340830ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08057971595792Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07